Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101582
Status:
COMPLETED
Last Update Posted:
2016-09-27
First Post:
2005-01-12
Brief Title:
Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer
Sponsor:
Swedish Orphan Biovitrum
Organization:
Swedish Orphan Biovitrum
Study Overview
Official Title:
Phase 3 Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin rHuKGF for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Radiotherapy With Concurrent Chemotherapy RTCT
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to test the safety and effectiveness of palifermin to determine if weekly doses can be safely administered to reduce the incidence occurrence of duration length of time and severity amount of pain of oral mucositis painful sores in the mouth Mucositis is a common side effect for patients receiving chemotherapy cancer-killing drug and radiotherapy cancer-killing x-rays for the treatment of head and neck cancer HNC
Detailed Description:
This study consisted of 2 phases The acute oral mucositis OM evaluation phase includes the time from randomization to the time of severe OM WHO Grade 3 or 4 resolution up to Week 12 or up to Week 15 for participants whose severe OM is not resolved at Week 12 In the acute OM evaluation phase participants were randomized to receive either a single IV dose of palifermin or placebo at 180 μgkg 3 days before the start of radiotherapy plus 7 once-weekly palifermin or placebo doses at the same dose level during a 7-week radiochemotherapy course In the long-term follow up phase participants are followed until death withdrawal of consent or loss to follow-up The long-term follow up phase is still ongoing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None